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mRNA-1018-H5 pandemic influenza vaccine for healthy adults

A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

Phase 3 Interventional ModernaTX, Inc. · NCT07496450

This trial will test whether two doses of the mRNA-1018-H5 vaccine produce a strong antibody response and are safe in adults 18 and older.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4000 (estimated)
Ages18 Years and up
SexAll
SponsorModernaTX, Inc. Industry-sponsored
Drugs / interventionsinfliximab, omalizumab, methotrexate, prednisone
Locations36 sites (San Bernardino, California and 35 other locations)
Trial IDNCT07496450 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional study enrolls adults aged 18 years and older to receive two doses of mRNA-1018-H5 or placebo. Blood samples will be collected to measure humoral immune responses, and participants will be monitored for safety and local and systemic reactogenicity. Eligible participants include generally healthy adults and those with clinically stable chronic conditions, while people who are pregnant or breastfeeding must meet specific criteria or are excluded. The study is being conducted at multiple outpatient clinical research sites in the United States.

Who should consider this trial

Good fit: Adults 18 years and older who are generally healthy or have stable chronic conditions, are not pregnant or breastfeeding (or meet the study's nonchildbearing criteria), and can comply with study visits and testing are ideal candidates.

Not a fit: People who are acutely ill or febrile within 72 hours, have a history of myocarditis, pericarditis, myopericarditis, Guillain–Barré syndrome, or who are pregnant or breastfeeding are likely ineligible and may not benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could provide an mRNA-based option that induces protective antibodies against H5 pandemic influenza strains.

How similar studies have performed: mRNA vaccine technology demonstrated high effectiveness for COVID-19, but mRNA H5 influenza candidates are relatively new and have limited large Phase 3 data so far.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
* Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:

  * Is a person of nonchildbearing potential (PONCBP) OR
  * Is a person of childbearing potential (POCBP)
  * A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.

Key Exclusion Criteria:

* Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
* History of myocarditis, pericarditis, or myopericarditis.
* History of Guillain-Barre syndrome.
* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
* Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
* Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
* Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
* Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
* Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
* Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.
* Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

Note: Other inclusion/exclusion criteria may apply.

Where this trial is running

San Bernardino, California and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions InfluenzaInfluenza VaccineModernamRNA-1018-H5Viral DiseasesVaccinesPandemic InfluenzaAvian Flu
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.